Unique ID issued by UMIN | UMIN000015257 |
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Receipt number | R000015632 |
Scientific Title | A prospective randomized study of "Fully covered" vs "partially covered" metallic stents for the management of biliary stricture by unresectable pancreatic cancer. |
Date of disclosure of the study information | 2014/09/26 |
Last modified on | 2015/01/21 22:35:15 |
A prospective randomized study of "Fully covered" vs "partially covered" metallic stents for the management of biliary stricture by unresectable pancreatic cancer.
"Fully covered" vs "partially covered" metallic stents for biliary stricture by unresectable pancreatic cancer.
A prospective randomized study of "Fully covered" vs "partially covered" metallic stents for the management of biliary stricture by unresectable pancreatic cancer.
"Fully covered" vs "partially covered" metallic stents for biliary stricture by unresectable pancreatic cancer.
Japan |
Biliary stricture caused by unresectable pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the efficacy of fully covered metallic stent and partially covered metallic stent.
Efficacy
Confirmatory
Pragmatic
Phase III
duration until stent dysfunction
1) overall survival
2) incidence of side effect
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Device,equipment |
Fully covered metallic stent
Partially covered metallic stent
Not applicable |
Not applicable |
Male and Female
1) Pancreatic head cancer with biliary stricture
2) Pathological confirmation is essential.
3) Stricture of bile duct is middle to lower common bile duct.
4) Clinical stage (UICC) is more than stage 2b.
5)Informed consent is essential.
1) PS > 4.
2) Severe complication of another organ.
3) A patient who gives no written IC.
4) A participating doctor thinks the patient is not proper for this study.
5) Prognosis will be within 3 months.
6) Initial drainage worsen the status of the patient.
200
1st name | |
Middle name | |
Last name | Kazuhide Higuchi |
Osaka Medical Colledge
2nd Department of Internal Medicine
2-7, Daigaku-cyo, Takatsuki-City, Osaka, Japan
072-683-1221
mpnus9345@gmail.com
1st name | |
Middle name | |
Last name | Kiyohito Tanaka |
Kyoto Second Red Cross Hospital
Department of Gastoroenterology
355-5, Haruobi-cho, Kamaza-dori, Marutamachi-Noboru,Kamigyo-ku, Kyoto-City, Japan
075-231-5171
seijin7705@gmail.com
Kansai Endoscopic Device Selection (EDS) Working Group
Kansai Endoscopic Device Selection (EDS) Working Group
Self funding
NO
2014 | Year | 09 | Month | 26 | Day |
Unpublished
Open public recruiting
2014 | Year | 03 | Month | 17 | Day |
2014 | Year | 03 | Month | 17 | Day |
2014 | Year | 09 | Month | 26 | Day |
2015 | Year | 01 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015632
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